- Responsible to write the clinical overview and non-clinical overview from the cited references should be involved in filing a dossier for Europe market.
- To compile the CTD Modules as per ICH requirement.
- To evaluate BE studies generated by CRO and utilised it to present in clinical overview.
- To compile Permitted Daily Exposure (PDE) report and Elemental Impurity Risk Assessment Report (EIRA).
- Provide scientific literature support for the regulatory submissions as and when required.
- Should be involves in communication with other teams during filing process for chasing documents and solving regulatory queries.
- Preparation of module 1 documents.
- Support the stake holders/submission activities by providing necessary information, justifications and reports.
ESSENTIAL EXPERIENCE, SKILLS AND ABILITIES:
- Should be Postgraduate in Pharmacy (Pharmacology).
- Good English and Excellent Communication skill.
- Able to work as per UK timing.
- Should have positive attitude towards work and have a team spirit.
Cab services available for Female candidates (Pickup & Drop).
Role:Clinical Research Associate/Scientist
Salary: 2,50,000 - 5,50,000 P.A.
Industry:Pharmaceutical & Life Sciences
Employment Type:Full Time, Permanent
PG:M.Pharma in Pharmacy
SYRI Research Pvt. Ltd.
SyriMed previously known as Thame Laboratories Licensed Medicines Division is one of the leading Pharmaceutical Companies in the UK specialising in the development, licensing, manufacture and marketing of liquid medicines.Established during 2004 in Ruislip, West London; SyriMed with the experience from the development and manufacture of unlicensed medicines started in 2014 to obtain marketing authorisations for its unlicensed liquid medicines. In May 2020, SyriMed held over 50 marketing authorisations for liquid medicines within the UK.SyriMeds success stems from its vibrant and productive Research and Development Department which develops and manufactures formulations for licensed medicines . All of SyriMeds formulations for which it holds marketing authorisations have been developed by SyriMeds own scientists.SyriMed manufactures licensed medicines in its own facilities that meet the quality requirements of EU Good Manufacturing Practice (GMP).Our in-house laboratories test the medicines manufactured to ensure they meet the strict requirements set by regulatory authorities.